6.

The Member State of affiliation may refuse to grant prior authorisation for the following reasons: the patient will, according to a clinical evaluation, be exposed with reasonable certainty to a patient-safety risk that cannot be regarded as acceptable, taking into account the potential benefit for the patient of the sought cross-border healthcare; the general public will be exposed with reasonable certainty to a substantial safety hazard as a result of the cross-border healthcare in question; this healthcare is to be provided by a healthcare provider that raises serious and specific concerns relating to the respect of standards and guidelines on quality of care and patient safety, including provisions on supervision, whether these standards and guidelines are laid down by laws and regulations or through accreditation systems established by the Member State of treatment; this healthcare can be provided on its territory within a time limit which is medically justifiable, taking into account the current state of health and the probable course of the illness of each patient concerned.

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Source: EUR-Lex (Cellar) · retrieved 2026-10-11 · Text as adopted (Official Journal); later amendments are not incorporated in this text.